Loratadine
Loratadine Tablet 10 mg
679164cc-7505-7ed4-13fe-87f06cb777d8
HUMAN OTC DRUG LABEL
Sep 22, 2025
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg
**APOTEX CORP.**NDC 60505-0147-1
Loratadine Tablets 10 mg
Non-Drowsy*
Antihistamine/Original Prescription Strength
†Compare to the active ingredient in Claritin®** Tablets**
Indoor & Outdoor Allergies
24 hour
Relief of
*Sneezing *Runny Nose *Itchy, Watery Eyes *Itchy Throat or Nose
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
SPL UNCLASSIFIED SECTION
Questions or comments?
Call1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time
|
Manufactured by: |
Manufactured for: |
|
Apotex Inc. |
Apotex Corp. |
|
Toronto, Ontario |
Weston, Florida |
|
Canada M9L 1T9 |
33326 |
Revised: August 2018
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Loratadine 10 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
|
adults and children 6 years and over |
1 tablet daily; not more than 1 tablet in 24 hours |
|
children under 6 years of age |
ask a doctor |
|
consumers with liver or kidney disease |
ask a doctor |
STORAGE AND HANDLING SECTION
Other information
- safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
- store between 2°C and 30°C (36°F and 86°F)
- protect from excessive moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose